Accessory appliance for use with a personal digital assistant

ABSTRACT

A system for controlling urination in a patient includes an implantable controller and an external device. The implantable controller includes circuitry and electrodes for stimulating the pudenal nerves in order to control urination. In addition, the implantable controller includes sensors for determining information on bladder fullness and for transmitting such information to an external device which is used for controlling the implanted controller. The external device will display when bladder filling exceeds a safe threshold level, allowing the patient and a caregiver to take appropriate steps to allow the patient to urinate.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/410,712, (Attorney Docket No. 42197-738.202), filed Jan. 19, 2017,now U.S. patent Ser. No. ______, which claims the benefit of priority toU.S. Provisional Application No. 62/280,639, (Attorney Docket No.42197-738.101), filed Jan. 19, 2016, the entire contents of which areincorporated herein by reference.

This application is also related to concurrently filed. U.S. patentapplication Ser. No. 15/410,692 (Attorney Docket No. 42197-738.201)which is incorporated by reference herein in its entirety for allpurposes.

BACKGROUND OF THE INVENTION Field of the Invention

Embodiments of the present invention relates to medical apparatus andmethods. More particularly, embodiments of the present invent relate tosystems and methods for allowing paralyzed and incontinent patients toselectively control urinary function with real-time informationregarding bladder fullness.

Many disorders can result in loss of a patient's ability to voluntarilycontrol bladder function. Most commonly, patients suffering from spinalcord injuries can lose not only the ability to voluntarily controlurination, but also the ability to sense when the bladder is full. Suchpatients have usually had to rely on the chronic use of a Foley catheterwhich is placed through the urethra and has a distal tip residing in thebladder. Such Foley catheters present a constant risk of infection whichis exacerbated by the frequent need to exchange for a new catheter.Moreover, Foley catheters usually drain into a bag which the patientmust carry when away from home or a treatment facility. The need tocarry the drain bag is a significant burden to many patients.

To at least partially overcome these problems, very promising newsystems have been proposed which allow patients and their caregivers toselectively stimulate the pudenal nerves to control voiding of thebladder. Such systems can eliminate the need for Foley catheters and aredescribed, for example, in US 2014/0249595, the full disclosure of whichis incorporated herein by reference.

While a significant advance, such pudenal nerve stimulation systems donot alert the patient when the bladder is filled. Since many patientswill have lost the ability to sense when the bladder is full, thesepatients may prolong periods between voiding, raising the pressure inthe bladder above safe levels and risking injury to the kidneys.

For these reasons, it would be desirable to provide improved systems andmethods for controlling urination via stimulation of the pudenal nerves.It would be particularly desirable if such systems and methods couldprovide feedback to a patient or caregiver regarding fullness of thepatient's bladder. Even more particularly, it would be desirable if suchfeedback were provided in real time, frequently or continuously, andcould provide alerts or alarms when certain pressure levels areapproached, reached, or exceeded.

Description of the Background Art

US 2014/0249595, has been described above.

SUMMARY OF THE INVENTION

Embodiments of the present invention provide improved systems andmethods for controlling urination in patients unable to voluntarilycontrol urination, typically paralyzed patients and patients sufferingfrom various forms of urinary incontinence. Systems according to thepresent invention for controlling urination comprise at least twoelectrodes configured to be implanted in the patient's abdomen todeliver current to the patient's pudenal nerve(s) in the form of anelectrical waveform. The waveform has one or more characteristics (e.g.,frequency, voltage, current etc.) configured to stimulate and/or blockthe patients pudenal nerve to stimulate and block the patient's pudenalnerve to cause a physiological action involved in the urination process.Such as actions may include opening of patient's urethra (which isaccomplished by blocking of the pudenal nerve), contraction of thebladder or relaxation of the bladder (the latter two accomplished bystimulation of the pudenal nerve. Typically, frequency is thecharacteristic which is used to produce a specific physiologic action.For example, high frequencies (above 4 khz, such as in a range of 4 to20 kHz, with a preferred value of about 5 or 6 khz) can be used to causeopening of the urethra by blocking signals from the pudenal nerve or theimplanted electrodes causing it to close, while lower frequencies areused to contract the bladder (e.g., 10 to 50 hz, with a preferred valueof about 20 hz), and very low frequencies are used to relax the bladder(e.g., 1 to 15, with preferred value of 5) to cease urination.

The system will also typically include an implantable sensor configuredto sense information corresponding to a degree of filling of thepatient's bladder. The sensor will typically being a pressure sensorconfigured to measure or sense pressure. Alternately, it may be a sensoradapted to measure or sense one or more of bladder wall stretch, bladderdistension, or the like. Systems of the present invention may furtherinclude an implantable controller configured to deliver current to theat least two electrodes, where the delivered current is able toselectively stimulate and selectively block the pudenal nerve as will bedescribed in more detail below. The systems may still further include anexternal device which is configured to receive information (e.g datasuch as bladder pressure or distention data) from the implantablesensor, display a value corresponding to the degree of filling of thebladder, and send signals to the implantable controller to initiatevoiding of the bladder when desired by the patient or the patient'scaregiver.

The systems of the present invention may optionally comprise at least athird electrode, wherein at least one of the three electrodes isconfigured to be implanted to deliver current to a contralateral pudenalnerve. Pudenal nerves are arranged in a bilateral fashion, and when twoelectrodes are employed, typically both will be connected to delivercurrent to one of the two sides, which may be designated as theipsilateral pudenal nerve. When a third electrode is employed, it willtypically be connected to the other pudenal nerve, which may be referredto as the contralateral pudenal nerve.

In specific embodiments, the implantable controllers are configured toselectively deliver current to the pudenal nerve in the form of a lowfrequency electrical waveform (e.g., in a frequency range of about 15 to50 hz) configured to stimulate the pudenal nerve to contract thepatient's bladder in order to void urine from the bladder. In order tovoid the urine, the patient's urinary sphincter must also be open toallow flow. Thus, the implantable controller will further be configuredto deliver current to the pudenal nerve in the form of a high frequencyelectrical waveform (e.g., in a frequency range of about 4 to 10 khz) inorder to block the pudenal nerve to open the urinary sphincter and allowthe flow of urine through the urethra. Specifically the high frequencyelectrical waveform acts to open the urinary sphincter by blockingsignals (e.g. action potentials) from the pudenal never causing theurinary sphincter to stay closed. In many embodiment the low frequencyand high frequency waveforms are delivered simultaneously an initiatedabout the same time. However embodiments also contemplate starting thehigh frequency waveform first so as to open the urinary sphincter andthen after a select period of time (e.g., 0.5 to 5 seconds) concurrentlydelivering the low frequency waveform to contract the bladder. The lowand high frequency current will typically be delivered to the sameipsilateral pudenal nerve. Optionally though, the higher frequencycurrent may also be delivered through the third electrode through thecontralateral pudenal nerve in order to block the contralateral nerve.Further optionally, when it is desired to terminate urination, thepatient or caregiver may initiate delivery of a current to the pudenalnever in the form of a very low frequency electrical waveform (e.g., ina frequency range of about 0.5 to 15 hz) through the first or secondelectrode to relax the patient's bladder.

A significant advantage of the systems of the present invention is thatthe patient and/or the patient's caregiver will have informationrelating to the filling of the bladder which allows them either toinitiate voiding of the bladder before the bladder is overfilled and thebladder pressure is raised to a potentially traumatic level. Also,embodiments of the invention provide information to the patient lettingthem know that it is time to urinate and be able to prepare forurination by providing a proper urinary receptacle or taking otherpreparatory steps necessary for the urination prior to actuallystimulating urination via the pudenal nerve. Such information caninclude, for example, that on the state of fullness or filling of theirbladder. The information on filling may include one or more of thedistention of the bladder, the tension in the bladder wall, the pressurewithin the bladder or the amount of urine within the bladder. Thisinformation may include either an absolute number or a percentage of amaximum.

Conveniently, the external device initiates voiding by sending a signalto the implantable controller to deliver the low frequency current tothe pudenal nerve to contract the bladder to cause the flow of urine outof the bladder and deliver the high frequency current to the pudenalnerve to open the urinary sphincter to allow urination. The externalcontroller will often be a combination or hybrid device employing aconventional “personal digital assistant,” thus described in more detailbelow, and an accessory appliance intended to be mated with the PDA toprovide the desired communication with the implanted controller.

In a second aspect of the present invention, methods for controllingurination in a patient unable to voluntarily control urination compriseproviding a control system having a visual or audible indication ofbladder fullness where the control system is configured to enable thepatient or caregiver to selectively stimulate the patient's pudenalnerve to initiate voiding of the bladder.

In specific aspects, the control system includes an implantablecontroller connected to the pudenal nerve by at least two electrodes andan external device configured to wirelessly communicate with theimplantable controller. The external device provides the visual oraudible signal or indication to the patient, allowing the patient toinitiate voiding through an interface on the external device. Beforeinitiating voiding, of course, the patient is able to prepare forurination by going to a toilet, providing a urinary receptacle, or thelike.

Initiation of voiding is accomplished via the external device whichcauses the implantable controller to contract the bladder and open thepatient's urinary sphincter. Optionally, the patient may simply waituntil the bladder has substantially or completely voided, or may tochoose to send a signal from the external device to implantablecontroller to relax the bladder to positively stop urination.

In a specific embodiment, the invention provides a method forcontrolling urination in a patient unable to voluntarily controlurination, comprising providing a control system having a visual oraudible indication of bladder fullness and being configured to enablethe patient or caregiver to selectively stimulate the patient's pudenalnerve to initiate voiding of the bladder; determining information ofbladder fullness and signaling the information to the patient; andutilizing the information to selectively stimulate the patient'sprudential nerve to initiate voiding of the bladder. The information onfilling may include one or more of the distention of the bladder, thetension in the bladder wall, the pressure within the bladder, thepressure/or force exerted by the bladder against an external surface,tissue or object (e.g., a sensor) the actual amount of urine within thebladder and/or a combination of one or more of all of these parameters.This information may include either an absolute number or a percentageof a maximum.

In a third aspect of the present invention, the invention provides anaccessory appliance for use with a personal digital assistant (PDA) orlike device which has a display, a user interface, a wirelesscommunication capability, a rechargeable battery, and a power port forrecharging the rechargeable battery (and optionally transmitting andreceiving digital data) and a body for containing or holding one or moreof the aforementioned components. The accessory appliance comprises ashell configured to be removably attached to the body of the PDA (orlike device), where the shell includes a port which is functionallyidentical to the power port of the PDA. A coupling bridge within theshell is configured to connect the port on the accessory appliance withthe port on the PDA when the shell is attached to the PDA body. Byhaving the coupling bridge between the accessory appliance port and thePDA port, recharging current from a PDA cable (when attached to wallcurrent or to a computer or other source) can be used to recharge arechargeable battery which is part of the accessory appliance. Theaccessory appliance will also be able to receive and send data via thecoupling bridge with both the PDA and any external computer or otherdevice connected via the PDA power cable to the accessory applianceport. The accessory appliance may further include at least one shortrange wireless communication antenna configured to communicate with animplanted device and circuitry connecting the short range wirelesscommunication antenna with the PDA.

Such accessory appliances will usually further include a microprocessoror other logic resources configured to receive data from the PDA and toprocess the data to provide instructions to be sent via the circuitryand the short range wireless communication antenna to the implanteddevice. The microprocessor of the accessory appliance can be connectedto the PDA via the coupling bridge or could be connected to the PDA viaa short range wireless link, such as a Bluetooth® link. In the latercase, the accessory appliance will provided with an appropriate shortrange antenna in addition to the antenna which is provided for linkingto the implanted device. It will be appreciated that transcutaneoussignal transmissions required by particular radio frequency or othertransmission characteristics, and a Bluetooth or other antenna on theaccessory device will not be sufficient to communicate with theimplanted device.

Combination of the accessory appliance and the PDA provides a number ofadvantages. The PDA can provide a display and user interface which canbe used to communicate with the implanted device, thus eliminating theneed to incorporate these features within the external device needed tocontrol the implanted device. In addition, the PDA can further providelogical programming to help control the implanted device, reducing theneed to provide processing capability within the accessory applianceitself. Usually, however, at least a minimal amount of processingcapability will be provided on the accessory appliance in order tocontrol the features and functions thereof, but the logical processingcapability can optionally be shared with that provided by the PDA.

In certain embodiments, the accessory appliance will further comprise amicroprocessor configured to receive data from the PDA and to processthe data to provide instructions to be sent via the circuitry and theshort range wireless communication antenna to the implanted device. Theprogrammed instructions for operating the implanted device may, however,reside primarily on the microprocessor of the accessory appliance, mayalternately reside on the microprocessor of the PDA, or may be sharedbetween in the two microprocessors as is well known in the art. In stillother embodiments they may reside on the Cloud and be down loaded orotherwise communicate with one or both of the aforementionedmicroprocessors.

In still further aspects of the accessory appliance, in addition tohaving a battery of the accessory appliance be recharged by therecharging capability of the PDA, the battery on the accessory appliancemay further be configured to recharge the PDA battery in the event thePDA battery needs recharging. In such aspects, particular embodiments ofthe invention contemplate the use of battery charge monitoringsoftware/logic programming resident on the accessory appliancemicroprocessor which monitor the charge (e.g. voltage and/or current)the PDA battery charge and automatically start charging the PDA batterywhen the PDA battery charge (e.g., voltage and/or current levels) fallbelow a designated threshold level.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a prior art system for selectively stimulating thepudenal nerves to control urination taken from US Patent Publication No.2014/0249595, the full disclosure of which has previously beenincorporated herein by reference. In particular, FIG. 1 depicts athree-channel system for stimulating pudendal nerves or branches thereofto perform one or more functions in the urination process. Pulsegenerator 10 is depicted as having three output channels. Wire leads 12and 13 are attached to electrodes 14 and 15, which are placed aboutpudendal nerve 20. Electrode 15 is shown distal to electrode 14. In thecontext of a method comprising blocking the EUS and/or anal sphincterand stimulating or inhibiting contractions in the bladder and/or rectum,electrode 14 would be used to stimulate or inhibit bladder and/or rectalcontractions, while electrode 15 would be used to block the EUS or analsphincter. As needed, wire lead 16 is attached to another electrode (notshown in FIG. 1) that is placed about the pudendal nerve on the otherside of the body to block the pudendal nerve on the opposite side. Pulsegenerator 10 is shown as implanted beneath skin 40. Output parameters ofthe pulse generator 10 can be controlled via a wired interface, butpreferably are controlled by wireless transmission, which can be carriedusing any suitable wireless protocol, such as radio frequency, IEEE802.11a/b/g, Bluetooth®, etc. Thus, in the embodiments of FIG. 1, anexternal controller 30 is depicted for communicating with the pulsegenerator 10. External controller 30 is depicted as having a display 32,such as an LCD, LED or OLED display, and a keypad 34 for entering datainto the external controller 30. External controller is depicted assending a wireless transmission 36 to pulse generator 10, though inanother embodiment, data can be transferred both to the pulse generator10 from the external communicator 30 and vice-versa, to permitmonitoring of one or more parameters of pulse generator 10, including,without limitation, output signal characteristics (e.g., frequency,amplitude, etc. as outlined above) and battery strength. Activity ofpulse generator 10 and external controller 30 typically ismicroprocessor controlled and software/firmware installed onto the pulsegenerator 10 and external controller 30 hardware may be used toimplement the described tasks, and to provide, for example and withoutlimitation, a GUI (graphical user interface) for the display 32, whichfacilitates use of the system. Both pulse generator 10 and externalcontroller 30 may comprise any suitable electrical and electroniccomponents to implement the activities, including, microprocessors,memory (e.g., RAM, ROM. Flash memory, etc.), connectors, batteries,power transformers, amplifiers, etc.

FIG. 2 is a schematic illustration showing normal innervation of theurinary tract.

FIG. 3 is a schematic illustration showing the system components of thepresent invention including the implanted components, the components ofthe external device and the optional connections to a power source andto a computer or other programming source.

FIG. 4 is a schematic illustration showing an embodiment of positioningof the implantable electrodes on the left and right Pudenal nerve.

FIGS. 5a and 5b are lateral view showing an embodiment of a cuffconfigured to be placed over a branch of the pudenal nerve (FIG. 5a );and placement of the cuff over a branch of the pudenal nerve (FIG. 5b )

FIGS. 6a and 6b are lateral and cross sectional views showing anembodiment of a bipolar electrode the positioning of the electrode onthe electrode cuff placed over a branch of the pudenal nerve.

FIGS. 7a and 7b are lateral and cross sectional views showing anembodiment of a tripolar electrode the positioning of the electrode onthe electrode cuff placed over a branch of the pudenal nerve.

FIG. 8 is a block diagram illustrating certain method steps according tothe present invention.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the invention provide devices, systems and methods fordelivering stimulating signals to paralyzed and other patients incapableof voluntary control of urinary function. Many embodiments provide thestimulating signals to these patients in the form of electrical currentsso as to so as to initiate and/or control their urinary function. Inparticular embodiments, systems of the present invention provide both anexternal device and an implanted device which are capable of working incombination to allow a patient to selectively control urinary functionby stimulating the pudenal nerve to initiate urination and optionally toterminate urination. Also in particular embodiments, the presentinvention provides real time information relating to the patient'sbladder fullness, usually by measuring and indicating pressure butoptionally, by measuring and indicating bladder distension or stretchingof the bladder wall.

The system components for initiating and optionally terminatingurination may be generally the same as those described in the systems ofU.S. patent publication 2014/0249595, which has previously beenincorporated herein by reference herein for all purposes. The systems ofthat patent publication, however, provide no means for giving a patientfeedback or information relating to bladder fullness, making it moredifficult for the patient to determine when to urinate. Moreover, thesystems of that patent publication rely on dedicated externalcontrollers where all system components are dedicated and intended foruse only in controlling the disclosed systems.

As many embodiments of the invention relate to approaches forcontrolling urinary function, particular for patients who are paralyzedand/or who are otherwise incapable of voluntary control of urinaryfunction a brief explanation will now be presented of the neuralcircuitry for control of the urinary function and what happens as resultof spinal cord injury. Referring now to FIG. 2, the neural circuitrythat controls the urine voiding process is complex and highlydistributed: it involves pathways at many levels of the brain, thespinal cord and peripheral nervous system and is mediated by multipleneurotransmitters. The two goals of normal bladder function are to storeurine until there is a socially acceptable time and place and to emptythe bladder in a coordinated fashion. The act of voiding is primarilycontrolled by the parasympathetic nervous system, primarily via thepelvic nerve (S2-S4); whereas, storage is primarily accomplished via thesympathetic nervous system (specifically at T10-L2, hypogastric nerve)which increases urethral closure pressure and inhibits parasympatheticnerves to the bladder as shown in FIG. 2. When the path between thesacral micturition center and the brain is intact, voiding iscoordinated and occurs by relaxation of the striated (external) urethralsphincter, contraction of the detrusor, and opening of the bladder neckand urethra. When the path between the brain and the sacral micturitioncenter is damaged or disrupted (e.g., by spinal cord injury) thecoordination between detrusor and sphincter during voiding is impairedin a condition known as Detrusor-sphincter dyssynergia or DSD. DSD iscommonly characterized by involuntary contractions of the externalurethral sphincter during an involuntary detrusor contraction. Sequelaeof DSD include hydronephoris, recurrent pyelonephritis, and renalfailure. DSD is caused by neurological lesions between the brainstem andthe sacral spinal cord and specific causes of DSD include: traumaticspinal cord injury, multiple sclerosis, spinal dysraphism, andtransverse myelitis.

Referring now to FIG. 3, a system 100 constructed in accordance with theprinciples of the present invention typically comprises both animplantable controller 102 and an external controller 120. Though insome embodiments, it may only include an implantable or externalcontroller. The implantable controller 102, will be of the type intendedfor long-term implantation and will have at least first and secondelectrodes 104 and 106 intended for connection to at least one branch ofthe pudenal nerves PN1 and PN2. Typically, electrodes 104 and 106 areconfigured for connected to the same pudenal nerve PN1. Optionally, athird electrode 108 will be provided, typically for connection to acontralateral branch of the pudenal nerves PN2. According to one or moreembodiments, third electrode 108 can be configured to be used bycontroller 120 to deliver a current to stop or otherwise inhibit bladdercontraction so as to stop urination. It may also be used as to block thepudenal nerve to open or keep open the urinary sphincter.

Of particular interest to the present invention, the system 100 willtypically further include a bladder fullness sensor 110, which maycorrespond any one or more of those sensors described earlier, includingfor example, pressure sensors, bladder distension sensors, bladder wallstretch sensors, and the like. One or more of these sensors maycorrespond to strain gauges includes MEMs based strain gauges known inthe art. According to various embodiments sensor 110 can be positionedon or adjacent the bladder wall. Further the sensor may have anatraumatic biocompatible coating or layer (e.g., silicone orpolyurethane) configured to minimize irritation of the bladder wallincluding that causing any type of wound healing response (e.g. collagenor cellular deposition or the like) so as to minimize any changes to themechanical properties to the section of the bladder wall to which thesensor is attached. This may also be accomplished through the size andshape of the sensor 110. Desirably, sensor 110 has a rounded shape so asto minimize any stress applied to the wall on its edges and also has astiffness less than equal to the bladder in various states ofdistention. The purpose of these sensors will be to sense informationcorresponding to a degree of bladder fullness to determine when thebladder has reached a threshold level of fullness as it is filledthrough the ureters UR from the kidneys (not shown). In variousembodiments, the information collected by sensors 110 can calibratedagainst the patient themselves by taking another measurement of bladderpressure during a set amount of bladder filling using a foley catheteror other like device and bladder pressure measurement method known inthe art. As discussed earlier, overfilling of the bladder can back urineinto the kidneys through the ureters presenting substantial risk ofmorbidity and mortality to the patient. Thus in use, embodiments of theinvention employing sensors 110 can reduce the risk of back flow ofurine into the kidneys and the associated risk of morbidity andmortality to the patient including that caused by kidney damage.

The implantable controller 102 will include a microprocessor 112 formanaging the functions of the controller, including controlling astimulator or pulse generator 114 to deliver stimulation energy to theelectrodes 104, 106, and optionally 108. The microprocessor 112 willfurther be connected to an antenna 116 which provides transmissioncapability to the implantable controller for wirelessly communicatingwith the external controller 120. Usually, the antenna 116 will bedesigned to operate at a radio frequency (RF) suitable fortranscutaneous communication. In particular embodiments, the antenna canbe configured to operate in the MICS frequency range known in the art.Optionally, the antenna 116 may further be configured to receive energyfrom a suitable RF source to be stored in an on-board battery (notshown) or other energy storage means known in the art (e.g., a capacitoror super capacitor) in a conventional manner. Alternatively, theimplantable controller may be configured to run on non-rechargeablebatteries requiring periodic battery replacement. In variousembodiments, antenna 116 may be a tuned or tunable antenna, may have avariety of shapes such as the coiled shaped as shown in FIG. 3 as wellas straight, square, rectangular or other like shape, with the length orother dimension selected for transmission at particular frequency orrange of frequencies. Further in particular embodiments, antenna 116 orother antenna described herein may be a stub antenna and/or a stub tunedantenna.

The external controller 120 may be a relatively simple controller of thetype described in US Patent Publication No. 2014/0249595, modified onlyto receive bladder fullness data from the implanted controller and todisplay such data on the display screen of that external device.Preferably, however, the external controllers on the present inventionwill be a combination or assembly including both a shell component 124and a conventional personal digital assistant (PDA) of a type commonlyavailable. As used herein, reference to a personal digital assistant(PDA) will mean any small, mobile, usually hand-held device that is ableto provide computing and storage information and retrieval capabilities.The PDA's use in the present invention will include at least a body,display, a user interface, wireless communication capability, arechargeable battery, and a power port for recharging the rechargeablebattery, and usually for also transmitting data to and from otherexternal devices, such as computers, tablets, cell phones and the like.The wireless communication capability can be in the form of an RFcommunication device e.g. an RF communication chip configured tocommunication in a BLUETOOTH or other related format. Exemplary PDA's atthe present time include “smart phones,” of the type sold by AppleComputer, Samsung, and others. In the future, such smart phones mayfurther evolve and may be identified by different names, but it isexpected that they still will be compatible with the external controlcomponents of the present invention.

Referring again specifically to FIG. 3, the shell 124 has a receptacleregion 126 which can slidingly receive the PDA so that a power/data port122 on the PDA is able to mate or otherwise engage with a power/dataplug 128 on the shell at the bottom of the receptacle region 126. Inalternative embodiments, receptacle region 126 can be configured toreceive the PDA by means of a snap or press fit over the PDA or by ajoining means such as use of VELCRO or a releasable adhesive. In theseand other embodiments, the receptacle region 126 is aligned andotherwise configured such that, when the PDA is fully inserted, the plug128 will be fully inserted into the port 122. In use, such embodimentsallows for a complete electrical and data connection between the PDA andthe accessory device without the user having to manipulate plug 128 orthe receptacle region 126. Further as described above, this can beachieved by the sliding movement alone of the PDA into the receptacleregion 126 and/or by the action of snapping or pressing the PDA into thereceptacle region 126 and/or pressing the receptacle region over thePDA. Such alignment for plug 128 can be achieved by control of thetolerances of the receptacle region 126 and/or plug 128, and/or the useof guiding structures or other guiding means (not shown) on thereceptacle region and/or receptacle region 126 and/or plug 128. It willbe appreciated that the plug 128 will typically be identical to the plugwhich is provided by the vendor of the PDA and intended for rechargingthe PDA and/or exchanging data with the PDA and the computer, tablet, orother external device. However, in other embodiments, plug 128 may notnecessarily be the same as the plug on the PDA and may be configured toattach to an adaptor to connect to the plug on the PDA. In variousembodiments, plug 128 may correspond to any of the USB connectors knownin the art including, for example, USB A, USB B, USB Micro A, USB MicroB, USB Mini A and USB Mini B. In particular preferred embodiments, plug128 may correspond to a USB Type C connector including for example a USB3.1 Type C connector. In use, use of a USB type C or other likeconnectors for plug 128 including USB 3.1 allows for one or more of thefollowing: i) easier connection and faster data transmission (e.g., upto about 10 Gbps.) between logic units 136 and one or more controllersassociated with the PDA, like device or external computer; ii) fasterand more complete charging of battery 134 (including an input power ofup to 100 watts at 20 Volts); and iii) compatibility with a greaternumber of PDA's, like devices or an external computer.

According to one or more embodiments of shell 126, plug 128 will beconnected to a further port 130 at the bottom of the shell by a couplingbridge 132. At a minimum, the coupling bridge will provide electricalconnections so that when a vendor-supplied plug 148 on cable 126(intended to be plugged directly into port 128 on the PDA) is pluggedinto the port 130, the PDA will see all connections as if the plug 148were plugged directly into the port 128. In addition, the couplingbridge 132 will provide a number of capabilities to the circuitry withinthe shell 124. At a minimum, the coupling bridge 132 will be connectedto a rechargeable battery 134 which is part of the shell so that therechargeable battery 134 will be maintained fully charged so long as thePDA is being used and is plugged in via the port 130.

In many embodiments, the coupling bridge 132 will usually be connectedto provide a data link to a processor or other logic unit 136 which ispart of the shell 124 and which controls communication of the shell withthe implantable controller 102. Logic unit 136 may also correspond toone or more of an Application Specific Integrated Circuit (ASIC), statedevice/machine, analogue device or other logic means known in the art.The processor or logic unit 136 will be connected (directly or operably)with an antenna 138 which is specifically configured to communicate withthe antenna 116 which is part of the implantable controller 102.Usually, both antennas 116 and 138 will be configured for radiofrequency transmission at a range selected to operate transcutaneously.Commonly, the antennas are coil-like devices, but other antennaconfigurations may be provided (e.g. a stub antenna). Optionally, theantenna and logic unit 136 may include a further antenna 142 intendedfor digital communication with the PDA and/or other external digitaldevices. Data communication between the PDA and the processor logic unit136 may thus be effected via the coupling bridge 132, via the digitalantenna 142 or both. Typically digital antenna 142 is an RF basedantenna configured for Blue Tooth communication with the PDS, however itmay configured for other frequency ranges outside the Blue Toothprotocol may also be used. For example, in particular embodiments, oneor more of antennas 116, 138, 142 and logic unit 136 may be configuredto communicate within the Medical Implant Communication Service (MICS)frequency band, typically between 402 and 405 MHz, though otherfrequencies are also considered.

Once the PDA is fully inserted into the shell 124, the combination ofthe PDA and the shell will be configured to be used as a single unitwith the patient and/or caregiver entering commands and data using thePDA interface, typically touch screen 121, and data being shown on thesame display 121. Optionally, data may be entered by speech recognitionmeans on the PDA and alarms and other signals may be provided by anaudio capability of the PDA.

In normal operation, the implantable controller 102 will be continuouslyor periodically monitoring bladder fullness using the sensor 110 andinformation regarding bladder fullness (e.g. an amount of bladderstretching or distension (absolute or percentage), an amount of bladderfullness (absolute or percentage) or bladder pressure) will continuouslyor periodically be transmitted via the microprocessor 112 and antenna116 to the PDA via antenna 138 and the processing logic unit 136.

In some cases, it will be desired only to recharge the PDA and battery134 of the shell 124 where the cable 146 may be plugged into the wallthrough a power supply 150. Alternatively, when it is desired toreprogram the PDA, the unit may be plugged into a personal computer 154via a USB plug 152 which goes into the USB port 156 on the computer.

Referring now to FIG. 4, in specific embodiment electrodes 104, 106 areconnected to the left pudenal nerve and electrode 108 to the rightpudenal nerve. Electrode 104 can be used to send very low frequencyelectrical waveforms (typically g. 1 to 10 hz) to stimulate the pudenalnerve to keep the bladder relaxed or a low frequency wave forms to openthe bladder (e.g. 10 to 50 hz). Electrode 108 is used to send highfrequency waveforms (e.g. 4 to 20 kHz) to block the right pudenal nerve(typically from natural nerve impulses) to open or keep the urinarysphincter EUS. Electrode 106 is also used to send a high frequencysignal to block the left pudenal nerve (e.g., from waveforms fromelectrode 104) so as to open or keep open the urinary sphincter.

Referring now to FIGS. 5-7 in various embodiments one more of electrodes104, 106 and 108 can be positioned on a cuff 200 configured to fit overand remain on branch of the pudenal nerve. The electrodes 104, 106 and108 can be positioned so as to have a radial or axial orientation inrelation to the cuff 200. The cuff 200 will usually have acircumferential opening 202 to allow to cuff to be fit over the pudenalnerve by the doctor. Cuff 200 is desirably fabricated from elasticmaterials such as silicone or urethane and has sufficient radial springforce to clamp down on and remain on the pudenal nerve once so placed.At the same time the dimensions and mechanical and material propertiesof the cuff are such that it desirably exerts not more than about 150 mmof pressure on the pudenal nerve or about 0.5 Newtons of force as forcesbelow this amount serve to maintain the health of the pudenal nerve.Also the cuff 200, including its inner surface 201 are desirablyconstructed from atraumatic biomaterials such as one or more ofsilicone, polyurethane, TEFLON, and the like so as to be atraumatic tothe pudenal nerve including the pudenal nerve sheath. The inner surfaceof cuff 200 may include one more drug eluting coatings known in the artto improve the biocompability of the coating and reducing anyinflammation or tissue adherence at the interface of the cuff with thepudenal nerve. Desirably cuff 200 is also constructed from insulativematerials so as to prevent the leaking of any current outside of thecuff and thus prevent unwanted stimulation or block of another portionof branch of the pudenal nerve.

Referring now to FIGS. 6a and 6b in various embodiments one more ofelectrodes 104, 106 and 108 can be figured as bi-polar electrodes 220having a positive and negative pole or portion 221 and 222 which may bepositioned radially or axially around cuff 200. Referring to now toFIGS. 7a and 7b , in still other embodiment one or more of electrodes104, 106 and 108 can be configured as tri-polar electrodes 230 having apositive pole or portion 231 and negative portions 232. In useembodiments of such a tripolar electrodes 230 serve to reduce theleakage of any current outside of cuff 200 and in turn reduce unwantedstimulation or blockage of a given branch of the pudenal nerve or asurrounding branch.

Referring now to FIG. 8, an embodiment of a method for utilizing anembodiment of system 100 to control urination along with an algorithm300 for doing so will now be illustrated. Algorithm 300 may beimplemented by an electronic instruction set (which may be in the formof a software module 301) resident on microprocessor 112 or other logicresources contained in controller 102 and/or on logic unit 136 or otherlogic resources on PDA/controller 120. In a first step 310, theimplanted sensor and controller to transmit bladder filling/information(e.g. in the form of bladder pressure, wall distention or wall stretchdata), either continuously or periodically to the PDA or a combinationof both. So long as the bladder is not filled (event 311), the PDA candisplay that status or can simply display nothing. In the event that thesignal indicating bladder filling exceeds a threshold level (event 312);however, the PDA will present an alert or alarm to the patient orcaregiver in step 320. The alarm may be a visual one displayed invarious graphic forms on the display screen. Alternatively, the alarmmay be audible via a small speaker on the PDA, or in some cases thealarm or alert may be both visual and audible. After receiving the alertor alarm, the patient or caregiver knows that the bladder should beemptied (e.g. by urination) in order to prevent over pressure of thebladder and potential damage to the kidneys. The patient or caregiverthen has time to go to a lavatory or obtain the appropriate receptaclesto collect the urine during urination. After appropriate preparationstep 330, the caregiver can use the PDA to signal the implantedcontroller to provide appropriate signals to the pudenal nerves in orderto initiate urination in step 340. Useful stimulation frequencies,currents and voltages for achieving a selected result are presentedbelow in Table 1. In specific embodiments the current can range fromabout 0.1 to 14.9 mA, with a preferred embodiments of about 1 to 14 maand more preferably in range of about 1 to 1 mA. It should beappreciated that embodiments of the invention are not limited to thesevalue, but rather other values are considered as well. It should also beappreciated that for these and other values and parameters cited herein,the term “about” means within +/−10% of a stated value for a dimension,characteristic, physical property and the like.

TABLE 1 Bladder Stimulation Parameters Current, Stimulation FrequencyVoltage Stimulation Site Result 0.5 to 15 Hz; preferred, 1 <15 mA; 50 VPudenal Nerve Relax Bladder to 10 Hz, preferred value of 5 Hz 10 to 50Hz; preferred 20 Hz <15 mA; 50 V Pudenal Nerve Contract Bladder Above 4kHz, 4 to <15 mA; 50 V Contralateral Pudenal Inhibit Contraction ofUrinary 30 kHz, preferred 4 to nerve Sphincter to open sphincter 20 kHz,more preferred 4 to 10 kHz, preferred value of about 6 kHz

According to one embodiment, urination can be allowed to terminate as aresult of complete voiding of the bladder and the stimulatory signalscan be terminated at that time. Alternately, the PDA and an implantedcontroller may be utilized to send a signal in step 340 to relax thebladder which will terminate urination even if the bladder is notcompletely voided. After urination is terminated, the patient andcaregivers may continue with other activities and rely on the systems ofthe present invention to again alert them when bladder filling hasexceeded the allowable threshold level. In various embodiments, delayscan be built into the system between the time the patent signals forvoiding and the voiding waveform is sent as well as between the timebetween when the waveform is sent to stop voiding after the patientsignals it (e.g., using the PDA). The delays can be in the tenths ofseconds or longer.

The foregoing description of various embodiments of the invention hasbeen presented for purposes of illustration and description. It is notintended to limit the invention to the precise forms disclosed. Manymodifications, variations and refinements will be apparent topractitioners skilled in the art. For example, embodiments of the devicecan be sized and otherwise adapted for various pediatric and neonatalapplications as well as various veterinary applications. They may alsobe adapted for the urinary tracts of both male and females. Further,those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, numerous equivalents to thespecific devices and methods described herein. Such equivalents areconsidered to be within the scope of the present invention and arecovered by the appended claims below.

Elements, characteristics, or acts from one embodiment can be readilyrecombined or substituted with one or more elements, characteristics oracts from other embodiments to form numerous additional embodimentswithin the scope of the invention. Moreover, elements that are shown ordescribed as being combined with other elements, can, in variousembodiments, exist as standalone elements. Hence, the scope of thepresent invention is not limited to the specifics of the describedembodiments, but is instead limited solely by the appended claims.

What is claimed is:
 1. An accessory appliance for use with a personaldigital assistant (PDA) having a body, a display, a user interface,wireless communication capability, a rechargeable battery and a powerport, said accessory appliance comprising: a shell configured to beremovably attached to the body of the PDA; a port functionally identicalto the power port of the PDA; a coupling bridge configured to connectthe port on the accessory appliance with the port on the PDA when theshell is attached to the PDA body; a rechargeable battery connected toreceive recharging current from the coupling bridge; at least one shortrange wireless communication capability configured to communicate withan implanted device; and circuitry connecting the short range wirelesscommunication capability of the accessory appliance with the PDA.
 2. Theaccessory appliance of claim 1, further comprising a microprocessorconfigured to receive data from the PDA and to process the data toprovide instructions to be sent via the circuitry and the short rangewireless communication capability to the implanted device.
 3. Theaccessory appliance as in claim 1, wherein the program for operating theimplanted device resides at least primarily on the microprocessor on theaccessory appliance.
 4. The accessory appliance as in claim 1, whereinthe microprocessor is programmed to operate with other programmingresiding substantially on the PDA and/or the implanted device.
 5. Theaccessory appliance of claim 1, wherein the rechargeable battery of theaccessory appliance is connected to selectively provide rechargingcurrent to the rechargeable battery of the PDA through the couplingbridge.
 6. The accessory appliance of claim 1, further comprising asecond short range communication capability configured to communicatewith a short range wireless communication capability on the PDA.
 7. Theaccessory appliance of claim 1, wherein the coupling bridge isconfigured to allow data exchange between the PDA and the circuitry ofthe accessory appliance.
 8. The accessory appliance of claim 1, whereinthe shell comprises an exterior case configured to cover a back side ofthe PDA.
 9. The accessory appliance of claim 1, wherein the shell isconfigured to be slidably attached to the shell of the PDA.
 10. Theaccessory appliance of claim 1, wherein the bridge is configured toalign the port on the accessory appliance with the port on the PDA whenthe shell is attached to the PDA body.